Ensuring Safe, Abundant Crops for a Growing World Population

Our Challenges

• Global population to exceed 9 billion by 2050, with most growth occurring in developing countries

Our Challenges

• Population growth will require at least 50% increase in calorie demand

• Only 5-10% more landglobally can go into agricultural production

• Climate change and water shortages

Our Solutions

• Improve yieldsWithout fungicides, yields of most fruits and vegetables would fall by 50-90%, making them unaffordable to many.

• Help reduce wasteWorld Bank estimates that in India, fruit and vegetable post-harvest losses amount to 40% of total production.

Our Solutions

• Society expects benefits of crop protection with minimal risks! This is done with:

• Stewardship• Training farmers and handlers• Integrated Pest Management, etc.

• Innovation• New products and active ingredients

• Regulation

Crop Protection Regulation

• Crop protection products are essential to agricultural production. But regulation of them key to ensure appropriate use and minimize environmental impact.

• Regulation should result in societal trust, confidence and benefits (i.e., safe, reliable food supply).

Crop Protection Regulation

• Under International Code of Conduct, governments have responsibility to regulate crop protection products in their countries.

• Crop protection regulations vary enormously worldwide due to social and political priorities and economic development.

Benefits of Effective Regulation solutions

Promotesinvestment

in new solutions Assures

safety and sustainability

Enables sharedresponsibility

andcompliance

Allows timely access to

technology

Global Regulatory System Challenges

Trade barriers

Not predictable Investment uncertainty

Lack of risk/benefitanalysis

Complex

Lack of Harmonization

Increasing R&D costs

Principles of Regulation (PoR)

Three components:• Meeting societal expectations of crop

protection regulation

• Recognized principles for effective regulation of crop protection products

• Identified best practices for effective registration of crop protection products

PoR: Societal Expectations

Regulations should be:

• Protective with clear goals

• Implementable with clear procedures

• Informed based on scientific evidence

• Enabling to allow access to technology

• Enforceable for accountability

PoR: Recognised Regulatory Principles

1. Compile sound policy framework to ensure high standards of product use and protection for human health and environment.

2. Use quality data and ensure transparency in regulatory process, while protecting confidential business information and intellectual property.

PoR: Recognised Regulatory Principles

3. Harmonise internationally wherever possible, while taking into account local needs and conditions.

4. Conduct use assessment of each product that is evidence-based using sound scientific principles.

5. Clarify responsibilities of each party throughout production and supply chains and call for responsible action.

6. Set up compliance monitoring system and active response process to manage adverse incidents.

7. Ensure that modern standards are applied to all products in market.

8. Assess impact of major changes to or revisions of regulations.

PoR: Recognised Regulatory Principles

PoR: Registration Best Practices

Gap Analysis Using PoR

Assessed regulatory systems against

PoR

Identified gaps and excesses

Systems initially analyzed:

Argentina Kenya

Bolivia India

Central America Morocco

Dominican Republic Paraguay

Chile Peru

Colombia South Africa

Ecuador Uruguay

Egypt USA

European Union Venezuela

Gap Analysis Results

Areas identified for improvement:

• Registration processMutual acceptanceIP ProvisionsTransparencyTimescales

• Approval processRisk assessmentRisk/benefit judgmentStewardship

Evaluating Regulation

Review your own regulatory process and compare to PoR

Identify gaps and excesses

Consider new approaches in spirit of continuous improvement

Ideal Outcomes

Universal adoption of recognised principles for effective registration of crop protection products and application of best practices.

Application of universal approaches to assessment of crop protection products and their uses.

Regulation is critical and should be both stimulant and safeguard for introduction of crop protection products.

Bottom Line

Our world faces huge challenges and agriculture is at heart of them.

Crop protection technology is vital part of solution to these challenges.

Thank you for your kind attention